Emily O’Reilly, the European Ombudsman, published an open letter to the London-based European Medicines Agency (EMA) today (16 May) expressing concern over the agency’s change in policy concerning clinical trial data transparency.

The EMA, which approves medicines in the EU, has for some time been in the middle of a battle between pharmaceutical companies and consumer groups over whether or not it should publish the result of clinical trials that companies must submit to the agency. The European Court of Justice is currently considering whether the EMA should be forbidden from publishing this data following legal action taken by two pharmaceutical companies.

In her letter, O’Reilly says she has seen evidence that the EMA is planning a “significant change of policy” which would bend to the wishes of the pharmaceutical companies. According to documents seen by the ombudsman, the EMA is planning to limit access to clinical trial data by imposing strict confidentiality requirements and by allowing data to be seen only on screen using an interface provided by EMA, as well as imposing wide restrictions on the use of such data.

O’Reilly said that the change “could undermine the fundamental right of public access to documents established by EU law.” She said that until now the EMA has appeared ready to adopt an approach to transparency in line with recommendations she had previously issued. She has asked Guido Rasi, the EMA’s director, to inform her by 31 May how EMA intends to deal with requests for public access to existing clinical trial data. She also asked him to list the reasons and the legal basis for what appears to be a significant change of policy.

A spokeperson for the EMA said the document O'Reilly is referring to is part of an ongoing consultation, and while it does indicate a direction of travel for the agency, "it's still a work in progress - nothing is finalised." The agency is continuing to meet with stakeholders to decide how to set its transparency policy.

Last month the European Parliament voted in favour of a legislative proposal to make clinical trial data public. This legislation must still be approved by member states.